Cleared Traditional

K851717 - 880/1 TO 890/4 VARIOUS TYPES OF PERIOTEAL ELEVATOR
(FDA 510(k) Clearance)

K851717 · Artiberia · Dental device

Jun 1985

Decision

50d

Days

Class 1

Risk

K851717 is an FDA 510(k) clearance for the 880/1 TO 890/4 VARIOUS TYPES OF PERIOTEAL ELEVATOR. This device is classified as a Elevator, Surgical, Dental (Class I - General Controls, product code EMJ).

Submitted by Artiberia (San Antonio, US). The FDA issued a Cleared decision on June 14, 1985, 50 days after receiving the submission on April 25, 1985.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4565.

Submission Details

510(k) Number	K851717 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 25, 1985
Decision Date	June 14, 1985
Days to Decision	50 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	—